NCT03551392

Pilot Intervention With Near Infrared Stimulation

Pilot Intervention With Near Infrared Stimulation: Revitalizing Cognition in Older Adults and Those With Parkinson Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 65 Years – 89 Years
• Healthy volunteers: Accepted

Summary

The current study will test whether age-related cognitive and mood changes in older adults and those will be affected by near infrared (NIR) stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.

Detailed description

This is a multi-site pilot study of the efficacy of NIR stimulation for enhancing cognition and mood in nondemented older adults. Sites include the University of Florida and University of Arizona. Prior research suggests that NIR exposure may be neuroprotective and increases energy available to neurons. The current study will test whether age-related cognitive and mood changes in older adults will be affected by near infrared (NIR) stimulation. The study team will randomize older adults into treatment groups and evaluate neuroimaging and cognitive outcome measures, before and after a 12-week intervention involving transcranial and intranasal NIR. The protocol will involve both " lab" and " home-based" NIR stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	Medx Console System	This intervention delivers near infrared (NIR) light using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.
DEVICE	Sham Medx Console System	This intervention uses sham application of near infrared light (NIR) using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.
DEVICE	Vielight 810 intranasal stand alone unit	Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.
DEVICE	Sham Vielight 810 intranasal stand alone unit	Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.

Timeline

• Start date: 2019-06-26
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2018-06-11
• Last updated: 2025-01-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study